EP1631214B1

EP1631214B1 - Stent delivery system having improved securement means

Info

Publication number: EP1631214B1
Application number: EP04750291A
Authority: EP
Inventors: Daniel Gregorich
Original assignee: Boston Scientific Ltd Barbados
Current assignee: Boston Scientific Ltd Barbados
Priority date: 2003-05-20
Filing date: 2004-04-16
Publication date: 2009-06-17
Anticipated expiration: 2024-04-16
Also published as: JP4740861B2; CA2523259A1; EP1631214A1; DE602004021593D1; US20040236406A1; JP2007500567A; US7235093B2; ES2328694T3; WO2004103217A1; CA2523259C; ATE433733T1

Abstract

The present invention comprises a securement member to improve securement of a stent upon an expandable balloon and delivery catheter, and to constrain portions of the stent before and during stent deployment. Generally, the securement member comprises a securement connector arranged to engage a catheter, at least one flexible connecting member coupled to the securement connector, and a locking member arranged to engage a portion of a stent.

Description

BACKGROUND OF THE INVENTION

Stents and stent delivery assemblies are utilized in a number of medical procedures and situations, and as such their structure and function are well known. A stent is a generally cylindrical prosthesis introduced via a catheter into a lumen of a body vessel in a configuration having a generally reduced diameter, and then expanded to the diameter of the vessel. In its expanded configuration, the stent supports and reinforces the vessel walls while maintaining the vessel in an open, unobstructed condition.
Both self-expanding and inflation expandable stents are well known and widely available in a variety of designs and configurations. Inflation expandable stents are crimped to their reduced diameter about the delivery catheter, maneuvered to the deployment site, and expanded to the vessel diameter by fluid inflation of a balloon positioned on the delivery catheter. The present invention is particularly concerned with delivery and deployment of inflation expandable stents.
There is currently a drive in the market to reduce the wall thickness of expandable coronary stents. Clinical results have shown that a reduced stent wall thickness improves vascular response.
There is also a market drive to make stents more flexible, allowing physicians to more easily maneuver stents through the bodily lumen, especially through the tortuous paths common in small vessels.
Thus, present stents commonly combine a thin wall thickness with high flexibility, which leads to various drawbacks associated with stent delivery. Stents with a reduced wall thickness typically have reduced strength in all directions. A stent with reduced strength has less ability to remain secure on the balloon and delivery catheter in the reduced state. Therefore, the stent has an increased risk of shifting positions on the catheter as it is maneuvered through the body. The stent must be able to securely maintain its axial position on the delivery catheter without translocation of its proximal or distal ends.
Reducing stent wall thickness may also reduce the axial strength of the stent. Lowered axial rigidity allows the stent to more easily pass through curved bodily vessels but can also lead to difficulty in stent placement during expansion.
When a stent with low axial rigidity is expanded by a balloon catheter, the stent may experience increased shortening or lengthening. If balloon inflation begins at the ends and continues inward, the deployed stent often has a shorter overall length after expansion. Conversely, if balloon inflation begins at the center and moves outwardly, the stent often experiences lengthening upon deployment.
Inflation expandable stent delivery and deployment assemblies are known which utilize restraining means that overlie the stent during delivery. U. S. Pat. No. 4,950, 227 to Savin et al discusses an expandable stent delivery system in which a sleeve overlaps the distal or proximal margin (or both) of the stent during delivery. During expansion of the stent at the deployment site, the stent margins are freed of the protective sleeve(s). U. S. Pat. No. 5,403, 341 to Solar relates to a stent delivery and deployment assembly which uses retaining sheaths positioned about opposite ends of the compressed stent. The retaining sheaths of Solar are adapted to tear under pressure as the stent is radially expanded, thus releasing the stent from engagement with the sheaths. U.S. Pat. No. 5, 108, 416 to Ryan et al. describes a stent introducer system which uses one or two flexible end caps and an annular socket surrounding the balloon to position the stent during introduction to the deployment site.
WO 98/07388 A1 discloses the features of the preamble of claim 1. It shows a stent delivery system to facilitate introduction placement of a stent, including a catheter having an expandable distal portion constructed and arranged for expanding the outer diameter of the catheter from a contracted state to an expanded state, a stent positioned around the distal portion of the catheter having a contracted condition and being expandable to an expanded condition, and being sized in the contracted condition to closely surround the catheter in a contracted state, the expandable distal portion of the catheter including a balloon within which there is included on a catheter shaft at least one body of a diameter larger than the catheter shaft to which the stent and balloon are fitted, for holding the stent in place until it is released therefrom by expansion of the balloon.
Further, from WO 02/067782 A2 an implant delivery system with interlock is disclosed which includes an elongated member having an implant mounting location. A self-expandable implant is mounted at the implant mounting location. The implant is held in a compressed orientation by a retractable sheath. An interlock structure prevents the implant from deploying prematurely as the sheath is retracted.
These known methods typically release the stent early in the balloon inflation procedure and do not maintain the axial dimensions of the stent during inflation.
There remains a need for stent delivery systems that constrain the axial dimensions of the stent until the stent is fully expanded.
Without limiting the scope of the invention a brief summary of some of the claimed embodiments of the invention is set forth below. Additional details of the summarized embodiments of the invention and/or additional embodiments of the invention may be found in the Detailed Description of the Invention below.
A brief abstract of the technical disclosure in the specification is provided. The abstract is not intended to be used for interpreting the scope of the claims.

BRIEF SUMMARY OF THE INVENTION

In one embodiment, the present invention is directed to a device for preventing stent movement during delivery. The device includes a securement connector arranged to engage a catheter, at least one flexible connecting member and at least one locking member arranged to engage a portion of a stent. The device is capable of constraining portions of the stent throughout expansion of the stent.
In another embodiment, the present invention is directed to a stent delivery system including a catheter, an expandable balloon a radially expandable stent and at least one radially expandable constrainment member. The constrainment member has a first end coupled to said catheter and a second end having at least one portion arranged to engage the stent. The constrainment member may remain engaged with the stent throughout expansion of the balloon.
In another embodiment, the present invention is directed to a stent delivery system including a catheter, an expandable balloon a radially expandable stent and at least one radially expandable constrainment member. The constrainment member generally comprises a circumferential band having a plurality of openings therethrough and at least one engaging portion. The constrainment member is arranged to at least partially overlay the balloon, and the at least on engaging portion is arranged to engage the stent. When the constrainment member and the stent are engaged, movement of the stent in the axial direction is prevented.
These and other embodiments which characterize the invention are pointed out with particularity in the claims annexed hereto and forming a part hereof. However, for a better understanding of the invention, its advantages and objectives obtained by its use, reference should be made to the drawings which form a further part hereof and the accompanying descriptive matter, in which there is illustrated and described a embodiments of the invention.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

A detailed description of the invention is hereafter described with specific reference being made to the drawings.

FIG. 1 is a perspective view of an embodiment of an inventive stent securement member.
FIG. 2 is a perspective view of an embodiment of an inventive stent securement member placed on a catheter with a stent in the reduced state.
FIG. 3 is a perspective view of an embodiment of an inventive stent securement member placed on a catheter with a stent, wherein the expansion balloon is expanded.
FIG. 4 is a perspective view of an embodiment of an inventive stent securement member placed on a catheter after deflation of the balloon.
FIG. 5 is a perspective view of an embodiment of an inventive stent securement member.
FIG. 6 is a perspective view of an embodiment of an inventive stent securement member placed on a catheter with a stent in the reduced state.
FIG. 7 is a perspective view of an embodiment of an inventive stent securement member placed on a catheter with a stent, wherein the expansion balloon is expanded.
FIG. 8 is a perspective view of an embodiment of an inventive stent securement member placed on a catheter after deflation of the balloon.
FIG. 9 shows another embodiment of an inventive stent securement member.
FIG. 10 shows another embodiment of an inventive stent securement member.
FIG. 11 shows another embodiment of an inventive stent securement member.
FIG. 12 shows another embodiment of an inventive stent securement member.
FIG. 13 shows another embodiment of an inventive stent securement member.
FIG. 14 shows another embodiment of an inventive stent securement member.
FIG. 15 shows another embodiment of an inventive stent securement member having a radiopaque marker.
FIG. 16 is a perspective view of an embodiment of inventive stent securement members placed on a catheter with a stent in the reduced state.

DETAILED DESCRIPTION OF THE INVENTION

While this invention may be embodied in many different forms, there are described in detail herein specific preferred embodiments of the invention. This description is an exemplification of the principles of the invention and is not intended to limit the invention to the particular embodiments illustrated.
For the purposes of this disclosure, like reference numerals in the figures shall refer to like features unless otherwise indicated.
In one embodiment, the present invention is directed to a stent securement member 10 as depicted in Figs. 1 - 4. The securement member 10 generally comprises a securement connector 14, a flexible connecting member 18 and a locking or engaging member 22.
The securement member 10 may be used with a stent 28 having an engagable portion 30 desirably located at the one or both ends of the stent 28. The locking member 22 is arranged to engage the stent engagable portion 30 and thereby constrain movement of the stent 28. Desirably, movement of the stent 28 at the stent engagable portion 30 will be constrained in two dimensions. The securement member 10 will prevent movement in the stent axial direction, as well as preventing rotation of the stent 28 about the balloon. Desirably, the securement member 10 will not restrain movement in the direction of radial expansion of the stent 28.
The securement member 10 will typically be used during stent delivery in conjunction with a catheter 34 and an expansion balloon 36. A balloon expandable stent 28 is typically crimped in a reduced state around a balloon 36 and catheter 34. The securement member 10 may be placed upon the catheter 34 with the locking member 22 engaging the stent engagable portion 30. The securement connector 14 may be coupled to the catheter 34 shaft, desirably by thermal bonding, adhesive bonding, swaging or by having a diameter of appropriate size to frictionally engage the catheter 34. Although the securement connector 14 desirably encircles the catheter 34, the securement connector 14 may be of any size, shape or material that adequately engages the catheter 34. The flexible connecting member 18 desirably overlays a portion of the expandable balloon 36 when the securement member 10 is in place.
The flexible connecting member 18 is desirably made from a shape memory material. The shape memory material may be a metal such as NiTi, CuZnAl, CuAlNi, MP35N, Elgiloy, Phynox, TiPtNi, TiPdNi, Cu-Zn, Cu-Al, Fe-Cr-Ni, Fe-Pd or Fe-Pt. The shape memory material may also be a polymer such as polymethylmethacrylate, polyvinylchloride, polynorbornene, trans-polyisoprene, polyurethane, styrene-butadiene copolymer or polyethylene. Further, the flexible connecting member 18 desirably will normally return to this reduced configuration.
Referring to Figs. 3 and 4, upon expansion of the balloon 36, the stent 28 is expanded. The flexible connecting member 18 is desirably sufficiently flexible and of sufficient length to allow displacement of the locking member 22 in a stent radial direction equal to the radial expansion of the stent 28. During expansion, the securement member 10 prevents movement of the stent engagable portion 30 in the axial direction, thereby preventing stent lengthening or foreshortening. Desirably, the securement member 10 will also constrain the stent engagable portion 30 from rotation about the balloon 36.
When the stent 28 has reached the full deployment diameter, the balloon 36 is deflated. Upon deflation, the securement member 10 desirably returns to its original reduced configuration. Desirably, this is accomplished by pseudo-elastic effect of the flexible connecting member 18. Desirably, the temperature at which the Austenite phase of the shape memory alloy finishes forming is lower than human body temperature. Thus, throughout the entire time period that the securement member 10 remains in the body, the shape memory alloy will remain in the pseudo-elastic state.
Alternatively, the shape memory alloy may be deformed in the Martensitic state. The flexible connecting member 18 may be returned to its original reduced configuration by introducing a heated fluid into the vessel. The shape memory alloy desirably experiences a phase change and transforms to an Austenitic state upon introduction of the heated fluid.
During deflation of the balloon 36, the securement member 10 may additionally apply pressure to the balloon 36, resulting in faster deflation times. As the balloon 36 deflates, the securement member locking member 22 becomes disengaged from the stent engagable portion 30.
Upon proper deflation of the balloon 36, the catheter 34, deflated balloon 36 and securement member 10 are free to move independently from the stent 28. Thus, the catheter 34, balloon 36 and securement member 10 may be removed from the patient.
In another embodiment, the present invention is directed to a stent securement member 10 as depicted in Figs. 5 - 8. The securement member 10 generally comprises a securement connector 14, a plurality of flexible connecting members 18 and a plurality of locking or engaging members 22. The flexible connecting members 18 may form a serpentine circumferential band.
The securement member 10 may be used with a stent 28 having a plurality of engagable portions 30 desirably located at one or both ends of the stent 28. The locking members 22 are arranged to engage the stent engagable portions 30 and thereby constrain movement of the stent 28. Desirably, movement of the stent 28 at the stent engagable portions 30 will be constrained in two dimensions. The securement member 10 will prevent movement in the stent axial direction, as well as preventing rotation of the stent 28 about the balloon. Desirably, the securement member 10 will not restrain movement in the direction of radial expansion of the stent 28.
The securement member 10 will typically be used during stent delivery in conjunction with a catheter 34 and an expansion balloon 36. A balloon expandable stent 28 is typically crimped in a reduced state around a balloon 36 and catheter 34. The securement member 10 may be placed upon the catheter 34 with the locking members 22 engaging the stent engagable portions 30 appropriately. The securement connector 14 may be coupled to the catheter 34 shaft, desirably by swaging or by having a diameter of appropriate size to frictionally engage the catheter 34. Although the securement connector 14 desirably encircles the catheter 34, the securement connector 14 may be of any size, shape or material that adequately engages the catheter 34. The flexible connecting members 18 desirably overlay a portion of the expandable balloon 36 when the securement member 10 is in place.
The flexible connecting members 18 are desirably made from a shape memory material, such as NiTi, CuZnAl, CuAlNi, MP35N, Elgiloy, Phynox, TiPtNi, TiPdNi, Cu-Zn, Cu-Al, Fe-Cr-Ni, Fe-Pd or Fe-Pt. The shape memory material may also be a polymer such as polymethylmethacrylate, polyvinylchloride, polynorbornene, trans-polyisoprene, polyurethane, styrene-butadiene copolymer or polyethylene. Further, the flexible connecting members 18 desirably will normally return to this reduced configuration.
Referring to Figs. 7 and 8, upon expansion of the balloon 36, the stent 28 becomes expanded. The flexible connecting members 18 are desirably sufficiently flexible and of sufficient length to allow displacement of the locking members 22 in a stent radial direction equal to the radial expansion of the stent 28. During expansion, the securement member 10 prevents movement of the stent engagable portion 30 in the axial direction, thereby preventing stent lengthening or foreshortening. Desirably, the securement member 10 will also constrain the stent engagable portion 30 from rotation about the balloon 36. Further, multiple locking members 22 help to accomplish a uniform and proportional circumferential expansion of the stent 28.
When the stent 28 has reached the full deployment diameter, the balloon 36 is deflated. Upon deflation, the securement member 10 desirably returns to its original reduced configuration. Desirably, this is accomplished by pseudo-elastic effect of the flexible connecting members 18. Desirably, the temperature at which the Austenite phase of the shape memory alloy finishes forming is lower than human body temperature. Thus, throughout the entire time period that the securement member 10 remains in the body, the shape memory alloy will remain in the pseudo-elastic state.
Alternatively, the shape memory alloy may be deformed in the Martensitic state. The flexible connecting member 18 may be returned to its original reduced configuration by introducing a heated fluid into the vessel. The shape memory alloy desirably experiences a phase change and transforms to an Austenitic state upon introduction of the heated fluid.
During deflation of the balloon 36, the securement member 10 may additionally apply pressure to the balloon 36, resulting in faster deflation times. As the balloon 36 deflates, the securement member locking members 22 become disengaged from the stent engagable portions 30.
Upon proper deflation of the balloon 36, the catheter 34, deflated balloon 36 and securement member 10 are free to move independently from the stent 28. Thus, the catheter 34, balloon 36 and securement member 10 may be removed from the patient.
Further embodiments of the invention are depicted in Figs. 9 -15.
Fig. 9 shows an embodiment of a securement member 10 comprising a securement connector 14, a plurality of flexible connecting members 18 and a plurality of locking or engaging members 22. The flexible connecting members 18 form a serpentine circumferential band, and locking members 22 work in conjunction with each other to engage the stent engagable portion 30. Further, the stent engagable portion 30 in this embodiment may be a rounded peak at an end portion of the stent 28.
Fig. 10 shows an embodiment of a securement member 10 comprising a securement connector 14, a plurality of flexible connecting members 18 and at least one locking or engaging member 22. The flexible connecting members 18 form a serpentine circumferential band, and locking members 22 are formed on a portion of the serpentine circumferential band peaks. The stent engagable portion 30 in this embodiment may be a rounded peak at an end portion of the stent 28.
Fig. 11 shows an embodiment of a securement member 10 comprising a securement connector 14, a plurality of flexible connecting members 18 and at least one locking or engaging member 22. The flexible connecting members 18 form a serpentine circumferential band, and locking members 22 are formed on a portion of the serpentine circumferential band peaks.
Fig. 12 shows an embodiment of a securement member 10 comprising a securement connector 14, a plurality of flexible connecting members. 18 and at least one locking or engaging member 22. The flexible connecting members 18 form a serpentine circumferential band, and locking members 22 are formed on a portion of the serpentine circumferential band peaks. The locking members 22 of this embodiment are designed to engage the stent engagable portion 30 to constrict motion in only the axial direction.
Fig. 13 shows another embodiment of a securement member 10. Locking members 22 in this embodiment comprise an "I" or an "H" shape, and stent engagable portions 30 are suitably shaped to receive the locking members 22.
Fig. 14 shows another embodiment of a securement member 10. Locking members 22 and stent engagable portions 30 comprise hooks in this embodiment.
Fig. 15 shows another embodiment of a securement member 10. Locking members 22 in this embodiment further may include a radiopaque marker 38.
Although only one securement member 10 has been shown attached to a catheter in Figs. 1- 8, it is within the purview of the invention to use multiple securement members 10 in conjunction with a single stent 28. Desirably, one securement member 10 will be used at each end of the stent 28, as depicted in Fig. 16. Optionally a plurality of securement members may be used at one or both ends of the stent. Thus, for example, one end of the stent may be provided with two or more securement members.
The above disclosure is intended to be illustrative and not exhaustive. This description will suggest many variations and alternatives to one of ordinary skill in this art. All these alternatives and variations are intended to be included within the scope of the claims where the term "comprising" means "including, but not limited to".
This completes the description of the various embodiments of the invention. Those skilled in the art may recognize other equivalents to the specific embodiment described herein which equivalents are intended to be encompassed by the claims attached hereto.

Claims

A device for preventing stent movement during delivery comprising:
• a securement connector (14) arranged to engage a catheter;

• at least one flexible connecting member (18) made from a shape memory material, said flexible connecting member (18) having a first end portion and a second end portion, the first end portion coupled to said securement connector (14); and

• a locking member (22) located at said flexible connecting member (18) second end portion arranged to engage a portion of a stent (28),
characterized in that the flexible connecting member (18) is sufficiently flexible and of sufficient length to allow displacement of the locking member (22) in a stent radial direction equal to the radial expansion of the stent (28).
The device of claim 1, further comprising a plurality of flexible connecting members (18).
The device of claim 2, wherein said flexible connecting members (18) are arranged to expand with the stent (28).
The device of claim 2, wherein the flexible connecting members (18) form a serpentine circumferential band.
The device of claim 1, wherein the flexible connecting member (18) is balloon expandable.
The device of claim 5, wherein the shape memory material has an Af temperature lower than normal human body temperature.
In combination, the device of claim 1 and a catheter (34), the catheter (34) having a balloon (36) with a stent (28) disposed thereabout, the stent (28) engaged to the device.
The combination of claim 7 wherein the stent (28) includes an engagable portion (30) arranged to engage said locking member (22).
The combination of claim 8 wherein the device is made of a shape memory material which is balloon expandable and which is programmed to return to an unexpanded diameter following balloon expansion.